First drug for COVID-19 approved
The most important news in healthcare: Friday, October 23rd
Everybody’s who’s anybody is talking about it: the FDA just approved the first and only drug for COVID-19. Today, we’ve broken down the steps leading up to that decision.
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COVID-19Remdesivir is remdesi-here
Source: CNN
The pulse:
Yesterday, the FDA approved remdesivir as the first drug available for the treatment of COVID-19. The antiviral produced by Gilead Sciences has been scrutinized in a series of clinical trials over the last few months. The results have been mixed. Today, we’re breaking down the evidence backing the approval and the not-so-scientific factors that may be coming in to play.
Emergency use authorization vs approval
You probably first heard about remdesivir back in May, when it was given an emergency use authorization (EUA) by the FDA. Now, it’s been given full approval. The difference between an EUA and full approval doesn’t just lie in semantics. An EUA can be given to a drug if there is reasonable evidence to believe that the product may be effective. A full approval on the other hand, must be backed by “substantial evidence of effectiveness and a demonstration of safety for the drug’s intended use”. In other words, there is a much higher standard required for a full approval, a standard that some argue remdesivir has failed to meet.
The data
The FDA based its full approval of remdesivir on three randomized controlled clinical trials. The first trial (conducted by Gilead) showed some evidence of a modest benefit– in hospitalized COVID-19 patients, remdesivir shortened recovery by about four days compared with the placebo group. However, there was no difference in survival rates. The other two trials also failed to show any statistically significant difference in mortality between the remdesivir group and the control group. We felt that this data supporting remdesivir was lackluster at best, even before an independent study from the WHO came out this week.
WHO?
Last week, the World Health Organization released the data from a global trial of four different COVID-19 treatments, including remdesivir. The study of over 11,000 people in 30 countries showed that remdesivir neither improved mortality nor delayed the need for ventilation in patients with severe cases. Gilead publicly rebuked the design of the study, though the WHO study enrolled far more patients than any of Gilead’s studies. In light of all this data, the inevitable question arose yesterday: is there really “substantial evidence” to support the FDA’s approval decision?
Now misstep to the left, now misstep to the right…
FDA commissioner Dr. Stephen Hahn has been under so much heat over the last few months, we think he could easily complete an episode of Hot Ones at this point. He’s made a series of bewildering decisions, many which may be at least in part due to political pressure being applied from the White House. In the early days of the pandemic, the FDA granted an EUA to the Trump-touted hydroxychloroquine, despite a paucity of data showing its effect in COVID-19. Three months later, the FDA revoked the EUA when evidence of hydroxychloroquine’s severe side effects when used in COVID-19 patients became clear. In August, the FDA issued an EUA for convalescent plasma treatment, which involves transfusing blood from recovered COVID-19 patients to patients currently fighting the disease in the hopes of transferring antibodies against the virus. At a White House event announcing the EUA, President Trump proudly reported his role in speeding up the process, noting “we broke the logjam [at the FDA] over the last week”. To date, the data seems to show that there is no benefit from the use of convalescent plasma in COVID-19 patients.
With the announcement of remdesivir’s approval less than two weeks before Election Day, many feel this is yet another example of Dr. Hahn caving to pressure from the White House to produce something, anything even when the data is scarce. Others have said that in the face of something so (everyone’s favorite word, wait for it…) unprecedented, it’s important to give weight to any idea that might work. Dr. Hahn himself has remarked, “I do not feel squeezed. I have been consistent in my message internally about using data and science to make decisions.” Still, his words seem at odds with the data and science behind the remdesivir decision.
Bottom line it for me.
With its latest approval of remdesivir, the FDA is continuing to follow its pattern of backing treatments with inconclusive evidence in the face of mounting political pressure.
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